Eligible patients were age 18 years or older with clinical stage cT2 to cT4 (> 2 cm)/cN0 to cN3/cM0 (> 2 cm) disease confirmed by a central laboratory (Targos Molecular Pathology, Kassel, Germany), to be HER2-positive breast cancer (immunohistochemistry 3+ [PATHWAY anti-HER2/neu {4B5} assay; Ventana Medical Systems, Santa Clara, CA]), or in situ hybridization–positive, defined as a HER2/CEP17 ratio of 2 or greater (INFORM HER2 Dual ISH assay; Ventana Medical Systems).15 (link) Both tests were conducted in parallel for all patients; however, only one test needed to be positive to establish HER2-positive status.
Protocol detail
HER2-Positive Breast Cancer Eligibility
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Corresponding Organization :
Other organizations : University of California, Los Angeles, Universidad Complutense de Madrid, GEICAM – Spanish Breast Cancer Group, University of Ulsan, Asan Medical Center, Ulsan College, National Taiwan University Hospital, Ludwig-Maximilians-Universität München, The University of Texas MD Anderson Cancer Center, Moscow City Oncology Hospital №62, Institut Génétique Nantes Atlantique, Jewish General Hospital, McGill University, Friedrich-Alexander-Universität Erlangen-Nürnberg, Universitätsklinikum Erlangen, Translational Research in Oncology, Albert Einstein College of Medicine, Montefiore Medical Center, Baylor College of Medicine
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Variable analysis
independent variables
- HER2-positive breast cancer status
- Not explicitly mentioned
- Age (≥ 18 years)
- Clinical stage (cT2 to cT4 (> 2 cm)/cN0 to cN3/cM0 (> 2 cm))
- HER2-positive status confirmed by central laboratory (Targos Molecular Pathology, Kassel, Germany) using immunohistochemistry (IHC 3+) or in situ hybridization (HER2/CEP17 ratio ≥ 2)
- Positive control: HER2-positive breast cancer samples
- Negative control: Not mentioned
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